- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05096260
Getting to Yes, Michigan! (G2YMI) (G2YMI)
Community-Centered Interventions for Improved Vaccine Uptake for COVID-19 (CIVIC): Getting to Yes, Michigan! (G2YMI)
This study entitled Community-Centered Interventions for Improved Vaccine Uptake for COVID-19 (CIVIC): Getting to Yes, Michigan!, is designed to increase vaccine uptake among populations that experience COVID-19 related disparities. The investigators will focus on the four counties within Michigan where a disproportionate burden of COVID-19 is within African Americans and Latinx communities, i.e., Wayne, Genesee, Kent and Washtenaw Counties. Using a community-based participatory research (CBPR) approach, CIVIC will leverage: its long term relationships with the communities involved, an established CBPR Steering Committee developed and the knowledge gained as a Community Engagement Alliance (CEAL) grant recipient, the resources and networks of the University of Michigan CTSA (MICHR), and the expertise of our academic partners to identify and understand factors that contribute to COVID-19 vaccine hesitancy in African Americans and Latinx communities in Michigan. The investigators will develop and test interventions based on community-centered approaches to achieve a primary goal of increased vaccine uptake.
The investigators will achieve this goal with the following aims:
- Increase understanding of the barriers and drivers of vaccine uptake and hesitancy;
- Increase vaccine uptake and decrease vaccine hesitancy through the implementation and evaluation of a multi-component intervention; and maintain, enhance, and evaluate the effectiveness of the CIVIC partnership to equitably engage all partners.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Like many states across the country, COVID-19 cases and deaths have impacted communities of color in Michigan at disproportionately higher rates than whites. A staggering reality is that while African Americans represent only 13.6% of Michigan's population, they represent 40% of the deaths from COVID-19.
- Half of the cases and deaths in Michigan occurred in Wayne County.
- Other Counties in the lower half of Michigan have similar disparities including Genesee, Washtenaw, and Kent.
- In Genesee County, where African Americans represent 20.3% of the population, they represent 35% of COVID-19 cases and 45% of deaths.
- In Washtenaw County, nearly half of the cases to date are located in two majority low-income zip codes in the city of Ypsilanti. African American residents, who make up 12% of the Washtenaw population, disproportionately constitute more than a quarter of the cases.
- And in Kent County, while 10.8% of the population is Latinx, this ethnic group makes up 32.4% of COVID-19 cases.
Preliminary data from the state reveal that these disparities will likely worsen due to significant hesitancy, fear, mistrust and misinformation regarding the COVID-19 vaccine if nothing is done to change current trends.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ken Resnicow, Ph.D.
- Phone Number: 734-904-3888
- Email: kresnic@umich.edu
Study Contact Backup
- Name: Emerson Delacroix, M.A.C.P.
- Phone Number: 7347642014
- Email: emmed@umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- Michigan Medicine
-
Contact:
- Meghan Spiroff, M.H.A.
- Phone Number: 810-919-9069
- Email: mairgood@med.umich.edu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Eligibility inclusion criteria:
- unvaccinated or unboosted adults 18 years and older who are interested in participating in the study OR vaccinated and boosted adults 18 years and older who are interested in becoming a Champion.
- Must be able to read and write in English or Spanish
- Must be able to receive SMS/MMS/text messages
Exclusion criteria:
- Persons under the age of 18
- unable to read or write English or Spanish
- unable or unwilling to receive SMS/MMS
- unwilling to consent
- for vaccine champions-unwillingness to complete communication trainings in English
No specific racial, ethnic, nor sex/gender group is excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Enrolled study participants receive Motivational Interviewing based SMS/MMS messages to increase COVID-19 vaccine uptake, and complete Baseline and Follow-up surveys.
|
Our primary framework that will guide the web content is Self-Determination Theory (SDT).
SDT differentiates between autonomous (conscious choice and are personally relevant) and controlled behavioral regulation (performed due to pressure or coercion by external or internal forces).
Messages that enhance autonomy and perceived competence and are consistent with a person's values and goals will be more effective in changing behavior than messages focusing on external rewards.
To link vaccination to broader values and goals, participants will select 3-4 goals from approximately 20 values/goals.
Individually tailored messages will link each of these values to vaccination.
We will also tailor testimonials based on member values and communication style preference.
|
No Intervention: Control
Enrolled study participants receive a simple website and complete a Baseline and Follow-up survey, after which they will receive the interventional Motivational Interviewing based SMS/MMS messages to increase COVID-19 vaccine uptake.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported COVID-19 Vaccine uptake
Time Frame: 6 months after the start of the intervention
|
The primary outcome is the binary variable of participant-reported vaccine uptake over the 6 month intervention period.
Participants will also be asked which vaccine, how many doses completed, location it was delivered, and date of delivery.
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6 months after the start of the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intention to uptake COVID-19 Vaccine
Time Frame: change from baseline at 6 months
|
Vaccine Intentions will be assessed by asking, on a scale of 0-10, "how likely is it that you will get the COVID-19 vaccine?", with 0 being very unlikely and 10 being very likely.
This will be analyzed using linear regression as described in the data analysis section.
|
change from baseline at 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ken Resnicow, Ph.D., University of Michigan
- Study Director: Emerson Delacroix, M.A.C.P., University of Michigan
- Principal Investigator: Erica Marsh, M.D., University of Michigan - Michigan Medicine
- Study Director: Arthi Ramakrishnan, MS, CCRP, University of Michigan - Michigan Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- G2YMI
- 1R01MD016867-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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